Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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3-52
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Standard | |
ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes |
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Scope/AbstractThis standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring. |
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 5.3.2 Pre-attached Leadwire Safety |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Section 5.3.2 conflicts with an existing regulation, see Section 898.12 Performance standard listed below.
Section 5.3.2 conflicts with existing final published guidance, see Section 5 Performance Characteristics listed below.
Section 5.3.2 conflicts with another recognized standard, see ANSI/AAMI EC53 listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§870.2360 |
Electrode, Electrocardiograph
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Class 2
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DRX
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§882.1320
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Cutaneous electrode. Electrode, Cutaneous
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Class 2
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GXY
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Relevant FDA Guidance and/or Supportive Publications*
21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables.
Class II Special Controls Guidance Document: Electrocardiograph Electrodes - Guidance for Industry and Food and Drug Administration Staff, Issued October 2007.
ANSI/AAMI EC53:2013 ECG trunk cables and patient leadwires.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |